Devyser announces its decision to establish a CLIA lab in Atlanta, Georgia, USA. By operating a CLIA lab, Devyser obtains complete control of the selling process, including reimbursement management, ensuring value-based pricing and improved margins. It also allows for closer interaction with physicians and patients. The company aims to have the lab CLIA certified and fully operational in the second quarter 2023.
“The establishment of an in-house CLIA lab is an important milestone in our ambition to strengthen Devyser’s presence in USA, the biggest IVD market in the world. Although USA accounts for a minor share of our total sales to date we are convinced that North America and the US will ultimately become our most important and profitable market,” says Fredrik Alpsten, CEO of Devyser.
In parallel to its present business model, the inhouse lab enables Devyser to offer test services directly to its US customers. The customers will send test samples to the lab, that will run the tests and provide the customers with the final test results. The lab will initially offer test services for Devyser’s top selling products. Devyser has signed a lease for the premises and started recruiting lab personnel. The initial workforce is expected to consist of five employees. The lab will also be used for training and education of customers.
“We see many advantages in operating a CLIA lab in the US. Direct contact with physicians and patients will be a critical success factor for our commercialization on the US market. Furthermore, it enables us to be in the driver’s seat of securing the quality and compliance that is necessary for reimbursement. We have seen several strong reference cases of successful launches of high-value diagnostics tests using this model,” says Theis Kipling, CCO of Devyser.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all US facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat diseases. Devyser has chosen Atlanta as the preferred location based on its standing as a center within the pharmaceutical and diagnostic industry, which will facilitate the recruitment of qualified lab personnel. The new premises are close to Atlanta airport, the biggest in the US, enabling fast shipments of blood samples. The location on the east side of the US will facilitate the collaboration with Devyser in Europe.News Source: PR Newswire